Dorsal root ganglion stimulation yielded higher treatment success rate for complex regional pain syndrome and causalgia at 3 and 12 months: a randomized comparative trial
Timothy R Deer, Robert M Levy, Jeffery Kramer, Lawrence Poree, Kasra Amirdelfan, Eric Grigsby, Peter Staats, Allen W Burton, Abram H Burgher, Jon Obray, James Scowcroft, Stan Golovac, Leonardo Kapural, Richard Paicius, Christopher Kim, Jason Pope, Thomas Yearwood, Sam Samuel, W Porter McRoberts, Hazmer Cassim, Mark Netherton, Nathan Miller, Michael Schaufele, Edward Tavel, Timothy Davis, Kristina Davis, Linda Johnson, Nagy Mekhail, Timothy R Deer, Robert M Levy, Jeffery Kramer, Lawrence Poree, Kasra Amirdelfan, Eric Grigsby, Peter Staats, Allen W Burton, Abram H Burgher, Jon Obray, James Scowcroft, Stan Golovac, Leonardo Kapural, Richard Paicius, Christopher Kim, Jason Pope, Thomas Yearwood, Sam Samuel, W Porter McRoberts, Hazmer Cassim, Mark Netherton, Nathan Miller, Michael Schaufele, Edward Tavel, Timothy Davis, Kristina Davis, Linda Johnson, Nagy Mekhail
Abstract
Animal and human studies indicate that electrical stimulation of dorsal root ganglion (DRG) neurons may modulate neuropathic pain signals. ACCURATE, a pivotal, prospective, multicenter, randomized comparative effectiveness trial, was conducted in 152 subjects diagnosed with complex regional pain syndrome or causalgia in the lower extremities. Subjects received neurostimulation of the DRG or dorsal column (spinal cord stimulation, SCS). The primary end point was a composite of safety and efficacy at 3 months, and subjects were assessed through 12 months for long-term outcomes and adverse events. The predefined primary composite end point of treatment success was met for subjects with a permanent implant who reported 50% or greater decrease in visual analog scale score from preimplant baseline and who did not report any stimulation-related neurological deficits. No subjects reported stimulation-related neurological deficits. The percentage of subjects receiving ≥50% pain relief and treatment success was greater in the DRG arm (81.2%) than in the SCS arm (55.7%, P < 0.001) at 3 months. Device-related and serious adverse events were not different between the 2 groups. Dorsal root ganglion stimulation also demonstrated greater improvements in quality of life and psychological disposition. Finally, subjects using DRG stimulation reported less postural variation in paresthesia (P < 0.001) and reduced extraneous stimulation in nonpainful areas (P = 0.014), indicating DRG stimulation provided more targeted therapy to painful parts of the lower extremities. As the largest prospective, randomized comparative effectiveness trial to date, the results show that DRG stimulation provided a higher rate of treatment success with less postural variation in paresthesia intensity compared to SCS.
Conflict of interest statement
Sponsorships or competing interests that may be relevant to content are disclosed at the end of this article.
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References
- Banks SM, Kerns RD. Explaining high rates of depression in chronic pain: a diathesis-stress framework. Psychol Bull 1996;119:95–110.
- Bean DJ, Johnson MH, Kydd RR. The outcome of complex regional pain syndrome type 1: a systematic review. J Pain 2014;15:677–90.
- Blackwelder WC. Proving the null hypothesis in clinical trials. Controlled Clin Trials 1982;3:345–53.
- Caspary T, Anderson KV. Patterning cell types in the dorsal spinal cord: what the mouse mutants say. Nature reviews. Neuroscience 2003;4:289–97.
- Cleeland CS, Ryan KM. Pain assessment: global use of the brief pain inventory. Ann Acad Med 1994;23:129–38.
- Curran S, Andrykowaski M, Studts J. Short form of the profile of mood states (POMS-SF): psychometric information. Psychol Assess 1995;7:80–3.
- Deer TR, Grigsby E, Weiner RL, Wilcosky B, Kramer JM. A prospective study of dorsal root ganglion stimulation for the relief of chronic pain. Neuromodulation 2013;16:67–72.
- Deer T, Mekhail N, Provenzano D, Pope J, Krames E, Leong M, Levy R, Abejon D, Buchser E, Burton A, Buvanendran A, Candido K, Caraway D, Cousins M, DeJongste M, Diwan S, Eldabe S, Gatzinsky K, Foreman R, Hayek S, Kim P, Kinfe T, Kloth D, Kumar K, Rizvi S, Lad S, Liem L, Linderoth B, Mackey S, McDowell G, McRoberts P, Poree L, Prager J, Raso Lou, Rauck R, Russo M, Simpson B, Slavin K, Staats P, Stanton-Hicks M, Verrills P, Wellington J, Williams K, North R. The appropriate use of neurostimulation of the spinal cord and the peripheral nervous system for the treatment of chronic pain and ischemic diseases: the neuromodulation appropriateness consensus committee. Neuromodulation 2014;17:515–50.
- Dellon AL, Adonian E, Rosson GD. CRPS of the upper or lower extremity: surgical treatment outcomes. J Brachial Plex Peripher Nerve Inj 2009;4:1–6.
- Dworkin R, Turk D, McDermott M, Peirce-Sandner S, Burke L, Cowan P, Farrar J, Hertz S, Raja S, Rappaport B, Rauschkolb C, Sampaio C. Interpreting the clinical importance of group differences in chronic pain clinical trials: IMMPACT recommendations. PAIN 2009;146:238–44.
- Geurts JA, Smits H, Kemler MA, Brunner F, kessles AG, van Kleef M. Spinal cord stimulation for complex regional pain syndrome type I: a prospective cohort study with long-term follow-up. Neuromodulation 2013;16:523–9.
- Harden RN, Bruehl S, Stanton-Hicks M, Wilson PR. Proposed new diagnostic criteria for complex regional pain syndrome. Pain Med 2007;8:326–31.
- Hogan QH. Labat lecture: the primary sensory neuron: where it is, what it does, and why it matters. Reg Anesth Pain Med 2010;35:306–11.
- Kemler MA, Barendse GA, van Kleef M, de Vet HC, Rijks CP, Furnee CA, van den Wildenberg FA. Spinal cord stimulation in patients with chronic reflex sympathetic dystrophy. N Engl J Med 2000;343:618–24.
- Koopmeiners AS, Mueller S, Kramer J, Hogan QH. Effect of electrical field stimulation on dorsal root ganglion neuronal function. Neuromodulation 2013;16:304–11.
- Kramer J, Liem L, Russo M, Smet I, Van Buyten JP, Huygen F. Lack of body positional effects on paresthesias when stimulating the dorsal root ganglion (DRG) in the treatment of chronic pain. Neuromodulation 2015;18:50–7.
- Krishna K, Buchser E, Linderoth B, Meglio M, Van Buyten JP. Avoiding complications from spinal cord stimulation: practical recommendations from an international panel of experts. Neuromodulation 2007;10:24–33.
- Kumar K, Caraway DL, Rizvi S, Bishop S. Current challenges in spinal cord stimulation. Neuromodulation 2014;17:22–35.
- Kumar K, Rizvi S, Bnurs S. Spinal cord stimulation is effective in management of complex regional pain syndrome I: fact or fiction. Neurosurgery 2011;69:566–80.
- Kumar K, Wilson J, Taylor R, Gupta S. Complications of spinal cord stimulation, suggestions to improve outcome, and financial impact. J Neurosurg Spine 2006;5:191–203.
- Liem L, Russo M, Huygen FJ, Van Buyten JP, Smet I, Verrills P, Cousins M, Brooker C, Levy R, Deer T, Kramer J. One-year outcomes of spinal cord stimulation of the dorsal root ganglion in the treatment of chronic neuropathic pain. Neuromodulation 2015;2015:41–9.
- Modovan AR, Onac IA, Vantu M, Szntagotai A, Onac I. Emotional distress, pain catastrophizing an expectancies in patients with low back pain. J Cogn Behav Psychother 2009;9:83–93.
- Oakley JC, Krames ES, Prager JP, Stamatos J, Foster AM, Weiner R, Rashbaum RR, Henderson J. A new spinal cord stimulation system effectively relieves chronic, intractable pain: a multicenter prospective clinical study. 2007;10:262–78.
- Robinson ME, Riley JL. The role of emotion in pain. In: Gatchel RJ, Turk DC, editors. Psychosocial factors in pain: clinical perspectives. New York: Guilford Press, 1999. pp. 74–88.
- Schott GD. Mechanisms of causalgia and related clinical conditions. The role of the central and of the sympathetic nervous systems. Brain 1986;109:717–38.
- Taylor RS. Epidemiology of refractory neuropathic pain. Pain Pract 2006;6:22–6.
- User's manual for the SF-36v2 health survey. 2nd ed Lincoln, RI: Quality Metric Inc, 2007.
- Van Buyten JP, Smet I, Liem L, Russo M, Huygen F. Stimulation of dorsal root Ganglia for the management of complex regional pain syndrome: a prospective case series. Pain Pract 2015;15:208–16.
- Ware JE, Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30:473–83.
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